BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3912891 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03842
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.   (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. PREDILATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. A 3.50X12MM PROMUS PREMIER STENT DELIVERY SYSTEM (SDS) WAS SELECTED; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE TARGET LESION AFTER FIVE ATTEMPTS. WHEN THE PHYSICIAN REMOVED THE SDS, THE SHAFT BROKE IN THE PHYSICIAN'S HANDS OUTSIDE OF AN UNSPECIFIED GUIDE. BUDDY WIRE TECHNIQUE WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391324 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952812350 16763726

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR